Electrosurgical Generator ES-100; Electrosurgical Generator ES-300

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K240975

by Beijing Taktvoll Technology Co., Ltd.

Identifiers

510(k) Number: K240975 FDA 510(k)
FDA Product Code: GEI FDA 510(k)
Models / Variants: Electrosurgical Generator (ES-100) FDA 510(k)EUDAMED
Electrosurgical Generator (ES-300) FDA 510(k)EUDAMED

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 878.4400 FDA 510(k)
Regulation Number: 878.4400 FDA 510(k)
Advisory Committee: General, Plastic Surgery FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Electrosurgical Generator ES-100 and ES-300 are medical devices classified as electrosurgical generators, designed to deliver controlled electrical energy for tissue dissection, coagulation, and desiccation during surgical procedures. These devices provide multiple operational modes, including monopolar and bipolar settings, to accommodate various clinical applications in general, plastic, and specialty surgical fields.

These generators are intended for use in operating rooms and clinical settings, supplied sterile or non-sterile as per manufacturer specifications. Both models are reusable and comply with FDA 510(k) clearance under the General, Plastic Surgery advisory committee, with the ES-100 and ES-300 bearing product codes GEI. They are regulated under the Medical Device Directive (MDD) and are not explicitly marked as MRI-safe or unsafe in the provided data.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ES-100 Advanced Electrosurgical Generator - taktvollmed.com, intelligent electrosurgical generator|HD Video Colposcope ... - Taktvoll, New generation intelligent electrosurgical generator - Taktvoll

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K240975	Class II	Active

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Manufacturer

Manufacturer: Beijing Taktvoll Technology Co., Ltd.

Sources (2)

FDA 510(k) K240975 24 fields · synced Sep 18, 2026
EUDAMED 1 fields · synced May 18, 2026